1. Is the company registered with FDA?
2. Does the company comply with applicable Quality System Regulation requirements?
3. Will the company permit you to visit its plant and review its quality manual?
4. Is sterilization performed by a commissioned and certified sterilization system, in accordance with ANSI/AAMI/ISO ST 11135 ST 1994?
5. Is the sterilization cycle re-qualified annually?
6. Are biological indicators used to monitor routine sterilization?
7. Are the sterilization systems routinely calibrated?
8. Is the residual sterilant level routinely tested?
9. Does the company have reprocessing procedures tailored to the specific types of medical devices you wish to have reprocessed, and has the company validated these procedures?
10. Is the product functionality routinely tested?
11. Does the company track the number of uses per device?
12. Does the company comply with Medical Device Reporting requirements?
13. Does the company have adequate liability insurance coverage?
Learn more about the Association of Medical Device Reprocessors.
Editor’s note: Look for more best practices concerning the use of reprocessed devices in ASCs in the Jan./Feb. 2011 issue of Becker’s ASC Review.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.